State legislative update: Lawmakers address prescribing practices and pill mills

Physicians and other health care professionals have encountered a relatively new type of state legislation in the past few years that affects the way they prescribe painkillers. This legislation has emerged in response to the growing epidemic of misuse and overprescribing of painkillers and the rising costs associated with overdoses and pill mills.

Nationwide, more than 116 million Americans struggle with chronic pain each year.¹ In 2008, painkillers were linked to 14,800 overdose deaths—more than for heroin and cocaine combined—and more than 12 million people reported using prescription painkillers for unintended reasons in 2010.2 The quantity of prescription painkillers sold to pharmacies, hospitals, and physicians’ offices was four times higher in 2010 than in 1999. In fact, the supply that year was large enough to medicate every American adult for one month with painkillers.²

This epidemic affects nearly every state in the U.S., which is why policymakers, medical associations, and government agencies, such as the medical boards, have joined the fight to combat this elusive issue on both the legislative and regulatory fronts. This article reviews the government programs in place presently, highlights examples of legislation enacted at the state level, and discusses alternative approaches to legislation.

Government efforts

Federal agencies have found that most prescription drugs enter the illegal market primarily though “doctor shoppers,” meaning people known to seek out and take advantage of physicians who inappropriately prescribe and pharmacists who improperly dispense medications.³

To prevent this practice, states have implemented prescription monitoring programs (PMPs). PMPs are state-run electronic databases designed to monitor and give a prescriber or pharmacist critical information regarding the patient’s controlled substance prescription history.² PMPs are currently in place in 38 states, and policymakers in more than 12 states and the District of Columbia have enacted new legislation to authorize PMPs.¹ PMPs must adhere to the following guidelines:

• Collect data on the physician who wrote the prescription and the pharmacies that dispensed the medication. Pharmacists are required by law to report the data; physicians are encouraged to do this but are not mandated to do so in most states.¹
• Serve as a central repository for the data collected.
• Provide a protocol describing how authorities and agencies can access the data.

The medical community has concerns about the accessibility of PMPs, and several barriers are preventing PMPs from realizing their full potential and widespread implementation. First, the Centers for Disease Control and Prevention (CDC) recommends that PMPs link to electronic health record (EHR) systems so that the information is readily available. However, some states do not use EHR systems.^1,2

Second, the federal government has not fully funded the 2005 National All Schedules Prescription Electronic Reporting Act, which must be reauthorized to support modernization of state-based PMPs.¹ Although many states have passed legislation with reporting requirements for physicians to use PMPs, budget constraints will prevent the programs from being realized or implemented, and, as a result, funding will be pulled. Unfortunately, until PMPs are funded and in place in every state, doctor shoppers will still be able to evade detection and obtain prescriptions for painkillers.

Other state legislative efforts

Following are examples of other types of prescription painkiller legislation that has been considered or enacted at the state level and that have received national attention.

Florida has one of the highest numbers of pill mills—a problem that is causing significant strain on the state. In 2010, the state enacted H.B. 7095, which established standards of care for physicians who prescribe narcotic-grade pills. The law requires physicians to register with the Florida Department of Health and to write prescriptions on counterfeit-proof paper. Physicians who overprescribe face a minimum fine of $10,000 and suspension of their license for six months. The law also bans physicians from on-site dispensing of the more commonly abused drugs, such as oxycodone and hydrocodone.¹

In 2011, Ohio passed H.B. 93 to address pill mills in the wake of record high incidences of accidental overdose deaths in 2007 and 2008. This law mandates licensure of pain management clinics, authorizes the state medical board to establish rules on when a physician should review the state prescription reporting database, severely restricts in-office dispensation of controlled substances, and establishes a Medicaid pharmacy lock-in program and prescription drug take-back program.³

Pill mill legislation H.B. 1 took effect in Kentucky on July 20, 2012, and imposes requirements not just for physicians practicing pain medicine, but for all practitioners who prescribe controlled substances. The bill places significant limits on who may own a pain clinic and how a pain clinic is operated, such as requiring a licensed physician to be present at the facility at least 50 percent of the time that patients are being seen.³ Additionally, the legislation requires Kentucky’s licensing boards, including the Kentucky Board of Medical Licensure and the Kentucky Board of Nursing, to enact new regulations that impose standards for physicians, nurses, and other practitioners when a Schedule II or Schedule III controlled substance is prescribed. These regulations require the practitioner to keep accurate, readily accessible and complete medical records on each patient receiving Schedule II and III prescriptions. These records must include medical history and physical exam; diagnostic, therapeutic, and laboratory results; evaluations and consultations; treatment objectives; discussion of risks, benefits, and limitations of treatments; medications, including date, type, dosage, and quantity prescribed or dispensed; and periodic reviews of a patient’s file.³

Under legislation that became effective in January 2012, health care professionals who dispense drugs in Oklahoma must report all scheduled narcotics that have been given to patient within five minutes of being dispensed. Oklahoma is the first state to enact real-time electronic prescription database requirements.⁴

S.B. 5516, which took effect in January 2012 in Washington State, specifies that rules affecting physicians and nonphysician prescribers offer specific instructions on how to evaluate and care for patients with chronic pain that is not due to cancer. It also requires written treatment plans, known as patient contracts, that may mandate periodic urine screenings.¹

Because of these stricter opioid laws, many physicians have decided to avoid prescribing the narcotics to circumvent regulatory and administrative burdens.⁵ Pill mill legislation imposes sweeping changes for pain clinics and prescribing practices, and, therefore, health care providers and their patients will face new challenges in treating and managing pain. While these bills often aid in preventing the pattern of drug abuse, physicians are often the primary agents for reducing a patient’s misuse of prescription drugs.

Alternatives

Many state medical associations have opposed the laws highlighted in this article because they use a one-size-fits-all formula, rather than allowing physicians to determine the best care for each patient. It is very difficult to write legislation that strikes a balance between averting misuse and maintaining patient access due to the fact that laws typically must be applied uniformly.

The Federation of State Medical Boards has published recommendations for model opioid prescription policies, which recognize the growing problem of misuse of prescription medications and provide model language that state boards may use to clarify their positions regarding the use of controlled substances to treat pain, alleviate physician uncertainty about such practices, and encourage better pain management. In summary, the model policy reflects significant progress made in the medical community’s understanding of pain management by:

• Acknowledging the inadequate management of pain and barriers to appropriate treatment
• Emphasizing the dual obligation of government to develop a system that prevents abuse, trafficking, and diversion of controlled substances while ensuring their availability for legitimate medical purposes
• Revising definitions of addiction, chronic pain, and physical dependence to reflect current consensus and expertise in the medical community
• Updating criteria for evaluating the appropriate management of pain

CME requirements

An alternative to restricting and monitoring a physician’s prescription practices is for state medical boards to mandate that physicians attend continuing medical education (CME) courses on pain management and opioid prescriptions. A total of eight states now require that at least some physicians take CME courses related to pain medication prescribing practices: California, Florida, Ohio, Oklahoma, Oregon, Rhode Island, Tennessee, and West Virginia.⁶ In other states, every physician, regardless of specialty, must complete a CME course on pain management and opioid prescriptions. Some physicians, however, oppose this sort of legislation, arguing that while these courses are appropriate for some specialties, they may be inappropriate for others.

Public health officials, state policymakers, and medical professionals are still learning how to best address the growing epidemic of misuse and abuse of prescription painkillers. There are many facets to the problem, and the concerns some health care professionals have expressed regarding the legislative and regulatory action taken thus far in many states must receive proper consideration. The laws are often too difficult, if not impossible, for some states to develop due to the cost of the technology needed for physicians to implement these requirements into daily practices. Furthermore, the policies are too uniform and general in how they are applied and often place the onus on the physician.

Misuse and the overprescribing of painkillers is an issue that will to continue to play out in state legislatures. At the time this article was published, the state legislatures in Kentucky, Iowa, New Jersey, New York, and Pennsylvania were considering bills aimed at preventing prescription drug overdoses.³ The College will continue monitoring these bills and will provide updates on their status through The ACS Advocate and the Bulletin.

References

1. O’Reilly KB. American Medical News. States try more aggressive Rx opioid controls, stricter oversight of physician includes setting dosage limits and requiring CME. Available at: www.ama-assn.org/amednews/2011/10/17/prl21017.htm. Accessed January 24, 2013.
2. Centers for Disease Control and Prevention. Policy impact: Prescription painkiller overdoses. Available at: www.cdc.gov/homeandrecreationalsafety/rxbrief/. Accessed January 24, 2013.
3. National Conference of State Legislatures. Prevention of prescription drug overdose and abuse. Available at: www.ncsl.org/issues-research/health/prevention-of-prescription-drug-overdose-and-abuse.aspx. Accessed January 24, 2013.
4. Centers for Lawful Access and Abuse Deterrence: The national prescription drug abuse prevention strategy 2011–2012 update. Available at: www.claad.org/downloads/CLAAD_Strategy2011_v3.pdf. Accessed January 24, 2013.
5. Federation of State Medical Boards. Responsible opioid prescribing: A physician’s guide. Available at: www.fsmb.org/pain-model-policy.html. Accessed January 28, 2013.
6. Krupa C. American Medical News. Hot-button issues drive state CME mandates. Available at: www.ama-assn.org/amednews/2012/02/13/prl20213.htm. Accessed January 24, 2013.